safety and efficacy study of oxazolidinones to treat uncomplicated skin infections

Conditions: Infectious Skin Diseases; Bacterial Skin Diseases; Staphylococcal Skin Infections; Streptococcal Infections; Abscess

Summary: the purpose of this study is to assess the efficacy, safety and tolerability of rx-1741, an oxazolidinone, versus linezolid, another oxazolidinone, in the treatment of uncomplicated skin and skin structure infections


Eligibility criteria:
inclusion criteria: * adult patients with usssi * adult (men and women) ≥18 years * females must be post-menopausal for at least 1 year or surgically sterile * sexually active males must use a barrier method of birth control during and for 30 days after the study * acceptable clinical diagnoses of usssi include, but are not limited to: simple abscess, impetiginous lesions, folliculitis, furunculosis, carbuncles, cellulitis * the infection is accompanied by 2 or more of the following local signs and symptoms: pain/tenderness, swelling, erythema, localized warmth, purulent drainage/discharge, induration, regional lymph node swelling or tenderness, extension of redness * a sample for microbiologic culture must be obtained from the primary infection site at the screening visit * the patient must require and be a suitable candidate for oral antibiotic therapy in the opinion of the investigator and be able to swallow tablets or capsules intact * a written, voluntarily signed informed consent must be obtained from the patient prior to the initiation of any study-related procedures exclusion criteria: * cellulitis (area greater than 10cm2), chronic or recurrent furunculosis, postoperative wound infection, leg ulcer, decubitus ulcer(s), erysipelas, progressive lymphangitis, acute paronychia or a deep tissue abscess such as pilonidal or breast abscess. also excluded are skin infections resulting from animal bites * patients with a complicated skin and skin structure infection as judged by the investigator * infections that can be treated by surgical incision alone according to the judgment of the investigator * treatment with the following anti-infective agents prior to study drug administration: systemic antibiotic within 7 days; azithromycin within 14 days; a long-acting injectable antibiotic within 30 days * any infection which requires the use of a concomitant antimicrobial agent, in addition to study drug * concomitant topical therapy at the infection site for the period within 48 hours prior to study drug administration through toc * a chronic or underlying skin condition at the site of infection or infections involving prosthetic materials * a wound secondary to burn injury or acne vulgaris * any infection site that requires: intraoperative surgical debridement; excision of infected area * documented or suspected bacteremia * fungal infection involving the nail bed or scalp at the primary usssi site * significant peripheral vascular disease * an abscess at an anatomical location where the incidence of anaerobic pathogen involvement is increased * patient receiving a daily dose of \> 15 mg of systemic prednisone or equivalent, for \> 10 days within the period starting 14 days prior to study drug administration or anticipated through toc * patient with known human immunodeficiency virus (hiv) infection. * medical history of hypersensitivity or allergic reaction to linezolid according to the judgment of the investigator * patients receiving serotonergic agents, selective serotonin reuptake inhibitors (ssris), or monoamine oxidase inhibitors (maois) * patients who have severe liver disease * history of pheochromocytoma, untreated hyperthyroidism, untreated or uncontrolled hypertension, carcinoid syndrome * evidence of uncontrolled, clinically significant (according to the judgment of the investigator) cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, or endocrine disease; malignancy or psychiatric disorder * current evidence of deep vein thrombosis or superficial thrombophlebitis * experienced a recent clinically significant coagulopathy * evidence of clinically significant immunosuppression * patient who previously enrolled in this study * patient who has previously enrolled in any other clinical trial within 4 weeks of enrollment through toc. treatment with an investigational drug within 4 weeks prior to study drug administration * patient residing in a chronic care facility * any underlying condition or disease state that would interfere with the completion of the study procedures and evaluation of the absorption of study drug